BP 805T: PHARMACOVIGILANCE (Theory)

Unit I                                            

Introduction to Pharmacovigilance

  • History and development of Pharmacovigilance
  • Importance of safety monitoring of Medicine
  • WHO international drug monitoring programme
  • Pharmacovigilance Program of India(PvPI)

Introduction to adverse drug reactions

  • Definitions and classification of ADRs
  • Detection and reporting
  • Methods in Causality assessment
  • Severity and seriousness assessment
  • Predictability and preventability assessment
  • Management of adverse drug reactions

Basic terminologies used in pharmacovigilance

  • Terminologies of adverse medication related events
  • Regulatory terminologies

Unit II             

Drug and disease classification

  • Anatomical, therapeutic and chemical classification of drugs
  • International classification of diseases
  • Daily defined doses
  • International Non proprietary Names for drugs

Drug dictionaries and coding in pharmacovigilance

  • WHO adverse reaction terminologies
  • MedDRA and Standardised MedDRA queries
  • WHO drug dictionary
  • Eudravigilance medicinal product dictionary

Information resources in pharmacovigilance

  • Basic drug information resources
  • Specialised resources for ADRs

Establishing pharmacovigilance programme

  • Establishing in a hospital
  • Establishment & operation of drug safety department in industry
  • Contract Research Organisations (CROs)
  • Establishing a national programme

Unit III                                                                           

Vaccine safety surveillance

  • Vaccine Pharmacovigilance
  • Vaccination failure
  • Adverse events following immunization

Pharmacovigilance methods

  • Passive surveillance – Spontaneous reports and case series
  • Stimulated reporting
  • Active surveillance – Sentinel sites, drug event monitoring and registries
  • Comparative observational studies – Cross sectional study, case control study and cohort study
  • Targeted clinical investigations

Communication in pharmacovigilance

  • Effective communication in Pharmacovigilance
  • Communication in Drug Safety Crisis management
  • Communicating with Regulatory Agencies, Business Partners, Healthcare facilities & Media

Unit IV 

Safety data generation

  • Pre clinical phase
  • Clinical phase
  • Post approval phase (PMS)

ICH Guidelines for Pharmacovigilance

  • Organization and objectives of ICH
  • Expedited reporting
  • Individual case safety reports
  • Periodic safety update reports
  • Post approval expedited reporting
  • Pharmacovigilance planning
  • Good clinical practice in pharmacovigilance studies

Unit V 

Pharmacogenomics of adverse drug reactions

  • Genetics related ADR with example focusing PK parameters.

Drug safety evaluation in special population

  • Paediatrics
  • Pregnancy and lactation
  • Geriatrics

CIOMS

  • CIOMS Working Groups
  • CIOMS Form

CDSCO (India) and Pharmacovigilance

  • D&C Act and Schedule Y
  • Differences in Indian and global pharmacovigilance requirements